Last updated: 11/07/2018 08:20:59
Special Drug Use Investigation for Botox® (botulinum) Spasticity (BOTOX is a registered trademark of Allergan, Inc.)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Special Drug Use Investigation for Botox® (botulinum) Spasticity
Trial description: The objective of this post-marketing surveillance study is to collect safety, efficacy and usage data on botulinum injection in subjects with upper or lower limb spasticity on the long-term use in clinical practice and to identify the factors affecting the safety or efficacy.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of adverse events in Japanese subjects with spasticity treated with botulinum injection
Timeframe: 1 year
Occurence of adverse events at remote sites
Timeframe: 1 year
Occurence of adverse events associated with pulmonary function
Timeframe: 1 year
Onset status of adverse events associated with convulsion
Timeframe: 1 year
Onset status of adverse events associated with accidents such as fall
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Drug: Botulinum Toxin Type A
Enrollment:
1038
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Sugimoto Kanami, Yamashita Yoshiyuki, Hara Terufumi and Yoshida Pascal.Safety and Efficacy of Botulinum Toxin Type A (BOTOX®) in Patients with Spasticity: Results of Special Drug Use Investigation. Prog Med.2015;35(9):95-108.
Medical condition
Mumps
Product
OnabotulinumtoxinA
Collaborators
Not applicable
Study date(s)
August 2011 to October 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Subjects with upper or lower limb spasticity
- Subjects must use botulinum injection for the first time
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with upper or lower limb spasticity
- Subjects must use botulinum injection for the first time
Exclusion criteria:
- Not applicable
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2014-14-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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